Novo's next-generation obesity drug shows 25% weight loss in women in late-stage analysis

Novo on Tuesday said its next-generation obesity drug, CagriSema, showed 25% weight loss on average among adult women in a new analysis conducted after a late-stage trial.

The Danish company said further work is needed to confirm the hypotheses of two post-study analyses. Still, the results are the latest evidence that the experimental injection can improve upon the weight loss and other benefits offered by Novo's GLP-1 drug semaglutide, the active ingredient in its blockbuster obesity shot Wegovy and diabetes counterpart Ozempic.

CagriSema, a combination of semaglutide and another drug called cagrilintide that targets the amylin pathway, is expected to launch early next year. Obesity drug leaders Novo and Eli Lilly have built new treatments around amylin, which involves a hormone released in the pancreas alongside insulin that helps regulate hunger and fullness, hoping it will give them a new revenue stream beyond existing GLP-1s.

In an analysis of roughly 2,300 women with obesity or who are overweight, CagriSema caused 25% weight loss on average at 68 weeks compared with 3% with placebo. The results are based on an ideal scenario in which all patients stayed on treatment without interruptions.

A second analysis of around 1,900 women assigned by their menopausal status found that weight loss reached 26.7%, 24.8%, and 23.1% in premenopausal, perimenopausal and postmenopausal women, respectively, at 68 weeks, if all patients remained on the drug. That compares with approximately 2% across menopause groups with a placebo.

Across both analyses, CagriSema was linked to reductions in abdominal fat, based on waist circumference, among women overall and across menopause stages, Novo added.

The results suggest that women may experience slightly more weight loss on CagriSema than a broader population of both men and women with obesity saw in the phase 3 trial.

Initial results from the study showed that CagriSema helped adults lose 22.7% of their weight on average at 68 weeks versus 2.3% in the placebo group. However, the majority of patients in the trial — around 67% of roughly 3,400 — were women.

Weight gain is very common for women during menopause. Declining estrogen levels can contribute to a slowdown in metabolism, making it easier for women to gain weight and harder to maintain muscle mass. After menopause, estrogen generally remains low and does not return to previous levels.

More than 86 million women in the U.S. are 40 and older, according to the U.S. Census Bureau, which are the years in which perimenopause, menopause and postmenopause occur.

"Many women with obesity or overweight experience weight gain as they move through menopause, and it is important to explore investigational products such as CagriSema across the reproductive lifespan," said Michelle Skinner Moore, Novo's interim head of clinical development, medical and regulatory affairs.

Wall Street has not appeared particularly excited about CagriSema, whose previous late-stage clinical trial results disappointed investors because the drug showed weight loss efficacy below their expectations. Novo, however, maintains CagriSema is effective and differentiated enough from its other drugs to draw significant demand.

Analysts expect CagriSema to generate $11.84 billion in sales for obesity specifically in 2028, according to a consensus estimate compiled by FactSet.